Advanced biological drugs that have demonstrated a significant improvement in safety or effect compared to existing treatments will be regarded as ‘drugs with no alternatives’ and allowed to receive expedited review in Korea.

Until now, only advanced biopharmaceuticals with limited scope of application (such as patients who have positive or negative biomarkers) compared to existing treatments or those for patients who are unresponsive to existing treatments were regarded as ‘drugs with no alternatives.’

However, the Ministry of Food and Drug Safety decided to expand treatment opportunities for patients with rare and incurable diseases by revising the regulations and allowing